Here is a collection of tweets about MedTech News in Americas, with hashtags of #GMedTechUSA, #GMedTechFDA, #GMedTechCanada.
; Pulse Medical (Chinese:上海博动医疗) Receives FDA Breakthrough Device Designation for μFR® System.
#GMedTechFDA
#GMedTechCardioVascular
https://g-medtech.com/news/pulse-medical-receives-fda-breakthrough-device-designation-for-%ce%bcfr-system/
We are aware of continuing reports of adverse events that were associated with use of EzriCare Artificial Tears and Delsam Pharma’s Artificial Eye Ointment, which were previously recalled due to potential bacterial contamination.
FDA continues to warn consumers and HCPs not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
We’re requesting feedback on factors we should consider when reviewing proposed modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors, often known as REMS administrators.
FDA is requesting feedback until 7/21/23 on factors the agency should consider when reviewing proposed changes to third party vendors resulting in proposed modifications to a risk evaluation and mitigation strategy (REMS): https://www.federalregister.gov/documents/2023/03/23/2023-05962/changes-to-third-party-vendors-for-risk-evaluation-and-mitigation-strategies-establishment-of-a
FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance is pleased to invite you to our flagship Regulatory Education for Industry (REdI) Annual Conference 2023 on June 5-9, 2023.
Join us virtually June 5-9 for #CDERSBIA’s Regulatory Education for Industry (REdI) Conference to learn from FDA’s regulatory experts in drug, device, & biologic centers.
Register: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2023-06052023
On Wednesday, we announced a new grants application period for funding of studies to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases in major species or to treat minor species.
On 5/26, FDA will open the first FY24 grant funding application period for animal drugs for minor uses and minor species (MUMS). We encourage eligible sponsors (or their research partners) w/ designated MUMS drugs to apply! FMI: https://www.fda.gov/animal-veterinary/cvm-updates/fda-opening-first-fy2024-grant-funding-application-period-animal-drugs-minor-uses-and-minor-species.
Also yesterday, we issued a draft guidance for industry titled, Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.
FDA has issued draft guidance intended to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus (T1D) and/or type 2 diabetes mellitus (T2D): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diabetes-mellitus-efficacy-endpoints-clinical-trials-investigating-antidiabetic-drugs-and-biological
Yesterday, we issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzen Innokin Technology Co. Ltd. who make Esco Bars products, and Breeze Smoke LLC, who import and distribute Breeze products.
Today, FDA issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products—Shenzen Innokin Technology Co. Ltd. who make Esco Bars products and Breeze Smoke, LLC who import and distribute Breeze products. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-puts-firms-responsible-esco-bars-and-breeze-two-popular-disposable-e-cigarette-brands-notice?utm_source=CTPTwitter&utm_medium=social&utm_campaign=ctp-enforcement
Today’s “FDA Roundup” includes e-cigarette product warning letters, a new grants application period related to animal drugs, registration for an upcoming FDA conference, and information regarding certain eye products. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-26-2023
Summer is upon us and it’s getting hot! Before you step outside for some fun in the sun, remember that sunburn isn’t just annoying, it’s a sign of short-term overexposure. Learn more about the effects of UV radiation on the body. https://go.usa.gov/xJYSp #DontFryDay #DontFryday23
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